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Director Quality Management Systems

Company: Vertex Pharmaceuticals Inc (US)
Location: Cambridge
Posted on: May 3, 2021

Job Description:

The Director, Quality Management Systems and Compliance - Cell and Gene, will be responsible for the execution of Vertex Cell and Gene Therapy (VCGT) quality systems including oversight of the implementation of policies, practices, procedures, standards, and systems necessary to ensure the compliance across multiple cell, gene and device site operations to global GMP regulations.  This role will oversee a team responsible for cell and gene vendor management in partnership with a global audit function, drive closure of deviations, CAPAs, OOS and change controls and establishing and maintaining document control at the site level.  The Director will drive strategic alignment of the VCGT quality team goals with projects and activities including but not limited to: integration into a global quality organization, participation in risk management activities and proactively pursuing continuous improvement post implementation.

Key Duties and Responsibilities:

  • Lead on-going departmental activities for areas of direct responsibility and when required, assist other Quality areas in the successful performance of these activities.

  • Establish and lead change control board for product changes

  • Write, review, analyze and revise complaints, change controls and CAPAs

  • Identify ways to improve efficiency and effectiveness of processes as part of the QMS

  • Be directly involved in and where appropriate, lead multiple process/product improvement projects which may include quality system process improvements, development of new methodologies and improving existing methodologies, data generation, report development and presentation

  • Ensure quality staff performs and approves root cause analysis and product impact assessments for investigations resulting from deviations and OOS.

  • Ensure raw material risk assessments are performed per USP/ATMP guidance

  • Perform risk assessments of new programs for entry into the GMP facility

  • Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies

  • Leads and manages complex projects/teams within corporate objectives and project timelines

  • Participates in cross-functional projects in Quality expert and leader role

  • Provides strategies to address compliance gaps or determines enhancements to cross-functional quality systems

  • As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

  • Participate/Lead risk management activities for VCGT QA

Knowledge and Skills:

  • Expert knowledge of global GMP requirements governing device or combination products

  • Ability to evaluate quality matters and make decisions utilizing risk-based approach

  • Experience in providing quality oversight of facility design, build and qualification

  • Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required

  • Experience building and leading exceptional Quality Assurance, Quality Systems teams

  • Expert knowledge of GMP, FDA, EMA and ISO regulatory requirements applicable to Device and/or Combination products

  • Strong knowledge of current industry trends with the ability to use the latest technologies

  • Working knowledge of: Aseptic practices and clean room design/operations, auditing techniques.

  • Strong leadership skills with the ability to thrive in a high throughput environment

  • Ability to lead and manage projects/teams within corporate objectives and project timelines

  • Successful in mentoring people managers

Education and Experience:

  • Bachelor's degree in relevant field is required

  • Typically requires 8 years of experience in addition to 2 years of management experience or the equivalent combination of education and experience

#LI-LM

Keywords: Vertex Pharmaceuticals Inc (US), Cambridge , Director Quality Management Systems, Other , Cambridge, Massachusetts

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